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Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Keogh Institute for Medical Research.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Keogh Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT00507286
First received: July 25, 2007
Last updated: January 27, 2009
Last verified: July 2007
History of Changes
  Purpose

Erectile dysfunction (ED or impotence) is a common medical condition affecting many men world wide. The most commonly used treatment for ED are oral medications like Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil). If these are not effective the use of an injection into the penis (intracavernosal injection or ICI) is necessary. However in some men neither of these therapies is successful.

Hypothesis: An adequate erection may be achieved in men with difficult-to-treat erectile dysfunction, when they are treated with a therapy of combination of tablet and penile injection, when a single treatment therapy has failed for these men.

Aim of the study is to test the safety and efficacy of a combination of Viagra and Caverjet Impulse in a group of men who had failed to achieve an adequate response to the maximum recommended dose of either Viagra, Cialis or Levitra and Caverjet Impulse, when these treatments were used alone.

20 men with difficult to treat ED will be given oral medication, intracavernosal therapy or the combination in a single-blind randomised study.

Informed consent will be signed prior to any study procedures being carried out. All participants are 'blinded' to their study treatments. Participants who have satisfactory response to any of the tablets or penile injections, will be excluded from the study.


Condition Intervention
Erectile Dysfunction
 Drug: combination of various doses of sildenefil and alprostadil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Using Oral Sildenafil and Intracavernosal Alprostadil Injection as a Combined Pharmacotherapy for Men With Difficult to Treat Erectile Dysfunction.

Resource links provided by NLM:

Drug Information available for: Alprostadil
U.S. FDA Resources

Further study details as provided by Keogh Institute for Medical Research:

Primary Outcome Measures:
  • Sexual Encounter Profile SEP2 and SEP3

Estimated Enrollment: 20
Study Start Date: May 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men aged 20 years and over
  • History of ED for at least 6 months
  • IIEF score <26
  • Failure to achieve an adequate response to the maximum recommended therapeutic dose of an approved ED treatments, when either of these treatments was used alone.

Exclusion Criteria:

  • Concurrent treatment with nitrate-containing medications
  • Significant cardiac, hepatic, renal or respiratory dysfunction
  • Systolic blood pressure of less than 100mm Hg
  • Myocardial infarction, serious cardiac arrhythmia, cardiac surgery, or stroke within the last 6 months
  • Significant penile fibrosis, curvature or infection
  • Reported significant side effects of using PDE5 inhibitors or alprostadil
  • Hypersensitivity to PDE5 inhibitors or alprostadil
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507286

Locations
Australia, Western Australia
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Keogh Institute for Medical Research
Investigators
Principal Investigator: Bronwyn G STUCKEY, MBBS,FRACP Keogh Institute for Medical Research
  More Information

No publications provided

Responsible Party: Professor Bronwyn Stuckey, Keogh Institute for Medical Research
ClinicalTrials.gov Identifier: NCT00507286     History of Changes
Other Study ID Numbers: Protocol No. 2005-166, Australia CTN: 2007/288
Study First Received: July 25, 2007
Last Updated: January 27, 2009
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Alprostadil
Platelet Aggregation Inhibitors
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013